Research

Medulloblastoma Treatment with GDC-0449

Identification of a Pharmacokinetic-Based Dose for GDC-0449 in Children with Recurrent or Refractory Medulloblastoma

Protocol Description

This Pediatric Brain Tumor Consortium Phase I study evaluates the new cancer drug GDC-0449 for use in treatment of pediatric brain cancers. Researchers will evaluate dose regimens, side effects and how the body processes the drug, in hopes of determining whether it will be an effective treatment for childhood medulloblastoma.

Eligibility Criteria

Subject to screening criteria, patients with recurrent or medulloblastoma that is recurring or has not responded to previous treatments will be considered for this study.
Boys: Ages 3 years and up
Girls: Ages 3 years and up

Requirements
Participants will take an oral dose of GDC-0449 daily for up to 13, four-week courses (one year of treatment). Blood tests, exams and various scans will be done throughout the treatment and a follow-up exam will be done 30 days after completion of the program.
Frequency of visits: Weekly
Duration: 13 months

Status: Open for Enrollment

Sources of Support
Pediatric Brain Tumor Consortium
National Cancer Institute

Additional Resources
Study description at National Institutes of Health